ForaCare FORA 6 Connect User manual

Multi-Functional Monitoring System
Sistema de Monitoreo Multifuncional
Owner’s Manual
Manual del Propietario

Dear FORA 6 Connect System
Owner:
Thank you for purchasing the FORA 6 Connect Multi-Functional
Monitoring System. This manual provides important information to help
you use the system properly. Before using this system, please read and
follow the instructions in this Owner's Manual.
The system measures both blood glucose and β-ketone levels. Regular
monitoring of your blood glucose and β-ketone levels can help you and
your doctor gain better control of your diabetes. Due to its compact size
and easy operation, you can use the FORA 6 Connect Multi-Functional
Monitoring System to easily monitor your blood glucose and β-ketone
levels anywhere, any time.
If you have other questions regarding this product, please contact the
place of purchase or call our customer service line at 888.307.8188
(8:30 am - 5:00 pm PST, Mon. - Fri.). For assistance outside these hours,
please contact your healthcare professional.
Version 1.0 2018/01
311-4183400-018
English

IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
The meter and lancing device are for single patient use only. Do not
share them with anyone including your family members! Do not use
on multiple patients!
All parts of the kit are considered biohazardous and can potentially
transmit infectious diseases, even after you have performed cleaning
and disinfection.
For more information, please visit
“FDA Public Health Notification: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne Pathogens:
Initial Communication” (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm23
4889.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One
Person Poses Risk for Transmitting Bloodborne Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specified by the
manufacturer.
3. Do NOT use the device if it is not working properly or if it is
damaged.
4. Do NOT under any circumstances use the device on newborns or
infants.
5. This device does NOT serve as a cure for any symptoms or diseases.
The data measured is for reference only.

6. Before using this device to test blood glucose and β-ketone, read all
instructions thoroughly and practice the test. Carry out all the
quality control checks as directed.
7. Keep the device and testing equipment away from young children.
Small items such as the battery cover, batteries, test strips, lancets
and vial caps are choking hazards.
8. Use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets etc.) may cause
damaging static discharges that may cause erroneous results.
9. Do NOT use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the accurate
operation.
10. Proper maintenance and periodical control solution tests are
essential to the longevity of your device. If you are concerned about
your accuracy of measurement, please contact customer service or
place of purchase for help.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS
BEFORE YOU BEGIN 1
Important Information 1
Intended Use 3
Test Principle 3
Contents of System 4
Meter Overview 5
Meter Display 6
Test Strip 7
Setting the Meter 8
MEASURING MODES 10
Three Measuring Modes for Blood Glucose Testing 10
One Measuring Mode for Blood Ketone Testing 11
BEFORE TESTING 12
Calibration for Ketone Testing 12
How to Code Your Meter (β-Ketone test) 12
Checking the Code Number (β-Ketone test) 13
Control Solution Testing 14
Performing a Control Solution Test 15
TESTING WITH A BLOOD SAMPLE 17
Preparing the Lancing Device for Blood Testing 17
Preparing the Puncture Site 17
Performing a Blood Glucose or β-ketone Test 18

METER MEMORY 21
Reviewing Test Results 21
Reviewing Day Average Results 22
DOWNLOADING THE RESULTS 23
Data Transmission via Bluetooth 23
MAINTENANCE 25
Battery 25
Caring for Your Meter 26
Disinfecting Procedures 27
Caring for Your Test Strips 29
Important Control Solution Information 30
SYSTEM TROUBLESHOOTING 31
Result Readings 31
Error Messages 32
Troubleshooting 33
DETAILED INFORMATION 34
Reference Values 34
Comparing Meter and Laboratory Results 35
SPECIFICATIONS 37
FEDERAL COMMUNICATIONS COMMISSION (FCC) STATEMENT 38

1
BEFORE YOU BEGIN
Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional
immediately.
If your blood glucose or β-ketone results are lower or higher than
usual, and you do not have symptoms of illness, repeat the test. If you
have symptoms or continue to get results which are higher or lower
than usual, follow the treatment advice of your healthcare
professional.
Use only fresh whole blood samples to test your blood glucose and
β-ketone. Using other substances will lead to inaccurate results.
If you are experiencing symptoms that are inconsistent with your
blood glucose or β-ketone test results and you have followed all the
instructions given in this owner’s manual, contact your healthcare
professional.
We do not recommend using this product on severely hypotensive
individuals or patients who are in shock. Readings which are lower
than actual values may occur for individuals in a
hyperglycemic-hyperosmolar state, with or without ketosis. Please
consult your healthcare professional before use.
Limitation:
–For in vitro diagnostic use (for use outside of the body only).
–For single user only.
–The meter and lancing device are for single patient use. Do not
share them with anyone including other family members! Do not
use on multiple patients!
Important Information

2
–All parts of the kit are considered biohazardous and can potentially
transmit infectious diseases, even after you have performed
cleaning and disinfection.
–Please read your FORA 6 Connect Multi-Functional Monitoring
System Owner’s Manual before you use the test strip. Use only
FORA 6 Connect Test Strips with FORA 6 Connect Multi-Functional
Monitoring System to obtain accurate results, and to be covered by
the manufacturer’s warranty.
–This system is not for use in patients with abnormally low blood
pressure or those who are in shock.
–This system is not for use in patients in hyperglycemic-hyperosmolar
state, with or without ketosis.
–This system should not be used on critically ill patients.
–This system should not be used on patients with impaired
peripheral circulation, severe dehydration as a result of diabetic
ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic
coma or shock.
–Keep test strips and lancets away from small children. If swallowed,
consult a doctor immediately for advice.
–Hematocrit: The hematocrit level is limited to between 20% and
70%. Please ask your healthcare professional if you do not know
your hematocrit level.
–Neonatal Use: These test strips are not for use with neonates.
–Altitude Effects: Altitudes up to 10,742 feet (3,275 m) do not affect
test results.